Module 3 - Strategic case studies in practice

P HARMACEUTICAL D EVELOPMENT

ICH Harmonised Tripartite Guideline

TABLE OF CONTENTS

PART I:

PHARMACEUTICAL DEVELOPMENT

1.

INTRODUCTION.................................................................................................. 1

1.1

Objective of the Guideline ........................................................................................1

1.2

Scope .........................................................................................................................1

2.

PHARMACEUTICAL DEVELOPMENT............................................................ 1

2.1

Components of the Drug Product .............................................................................3 2.1.1 Drug Substance ............................................................................................ 3 2.1.2 Excipients ..................................................................................................... 3 Drug Product ............................................................................................................3 2.2.1 Formulation Development............................................................................ 3 2.2.2 Overages ....................................................................................................... 4 2.2.3 Physicochemical and Biological Properties ................................................. 4

2.2

2.3

Manufacturing Process Development ......................................................................5

2.4

Container Closure System........................................................................................6

2.5

Microbiological Attributes ........................................................................................6

2.6

Compatibility ............................................................................................................7

3.

GLOSSARY ............................................................................................................ 7

PART II:

ANNEX TO PHARMACEUTICAL DEVELOPMENT

1.

INTRODUCTION.................................................................................................. 9

2.

ELEMENTS OF PHARMACEUTICAL DEVELOPMENT ............................ 10

2.1

Quality Target Product Profile...............................................................................10

2.2

Critical Quality Attributes .....................................................................................11

2.3

Risk Assessment: Linking Material Attributes and Process Parameters to Drug Product CQAs .........................................................................................................11

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